Supreme Court May Hear Biosimilar 180-Day Notice Suit

How soon after approval by the Food and Drug Administration (FDA) can a biosimilar be sold on the market? For a conventional generic drug, that is pretty much completely up to the manufacturer. For a biosimilar maker, they have to sit and wait.

The US Supreme Court has asked the Obama Administration for its views on the contentious 180-day notice period, mandated by law, that biosimilar manufacturers must give to makers of innovator products, indicating their intention to go to market.

The Biologics Price Competition and Innovation Act (BPCIA), which authorized the biosimilar approval pathway, also set the timing of when a biosimilar can be launched. Specifically, BPCIA stated that a biosimilar manufacturer must give 180-day notice to the innovator’s manufacturer before the agent can be launched. The original notion was that this 6-month period would allow for the resolution of any patent dispute brought by the innovator drug maker. This seems unnecessary in reality, as patent disputes have been initiated and underway for many months/years before FDA approval is given. Instead, the 6-month notice period is undully delaying product launch (and depriving the government and the public of cost savings), according to Sandoz, which petitioned in February for the US Supreme Court to decide the matter.

In 2015, Sandoz contended that the law allowed it to give Amgen notice of its marketing plans for Zarxio® before FDA approval was granted. The federal appeals court did not agree, forcing Sandoz to wait essentially another 6 months before going to market.

According to industry observer Ed Silverman, this means 2 things: (1) that it is likelier that the Supreme Court will hear the case and (2) that the Obama Administration, which had lobbied for shorter exclusivity periods than was actually granted in BPCIA (7 yr vs. 12 yr), may have another chance to influence how quickly biosimilars are brought to the marketplace.

Sandoz argues that it should be allowed to provide this notice well before FDA approval, as patents are being disputed well before hand; Amgen counters that notice of intention to launch is moot without FDA approval. Of course, with an 8-member Supreme Court, a tie would allow the appeals court decision to stand.